Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06419673

Serplulimab Plus Chemoradiotherapy for Stage III-IVA Cervical Cancer

This study is a prospective, multicenter, randomized, open controlled clinical trial aimed at evaluating the effectiveness and safety of serplulimab plus chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cervical Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

About this study

Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival (OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this, the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024. This prospective, multicenter, randomized, controlled clinical trial study aims to evaluate the effectiveness and safety of serplulimab induced and combined chemoradiotherapy in FIGO 2018 stage III or IVA cervical squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma patients who have not received prior treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Age ≥ 18 years and ≤ 75 years at time of study entry.
  • Has histologically-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
  • The International Federation of Gynecology and Obstetrics (FIGO) 2018 Stages III-IVA.
  • Diagnosed with PD-L1-positive (combined positive score ≥1).
  • Has not previously received any definitive surgical, radiation, or systemic therapy for cervical cancer.
  • WHO/ECOG performance status of 0 or 1.
  • Patient must have at least one measurable disease as defined by RECIST 1.1.

Main Exclusion Criteria:

  • Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), anti-programmed cell death receptor ligand 1 (PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent o..
  • Ongoing participation in another clinical study, or planned initiation of treatment in this study less than 28 days from the end of treatment in the previous clinical study.
  • Known history of serious allergy to any active ingredie or any excipients list in monoclonal antibody.
  • The patient has other factors that, in the judgment of the investigator, may lead to forced early termination of the study.

Treatment and study plan

Serplulimab

Drug

Serplulimab will be administered by intravenous infusion at a dose of 300mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.

Cisplatin

Drug

IV infusion

carboplatin

Drug

IV infusion

Brachytherapy and External Beam Radiotherapy

Radiation

Brachytherapy and External Beam Radiotherapy

Primary outcomes

  1. Progression-Free Survival(PFS) at Month 36

    Time frame: Up to approximately 46 months.

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, or by histopathologic confirmation of suspected disease progression, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD. PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at Month 36 using the entire PFS data up to the cut-off date.

Secondary outcomes

  1. Overall Survival (OS) at Month 36

    Time frame: Up to approximately 46 months

    Overall Survival (OS) at Month 36 [ Time Frame: Up to approximately 46 months ] OS, defined as the time from initiation of study treatment to death from any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 36 using the entire OS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 46 months.

  2. Objective Response Rate (ORR)

    Time frame: Baseline up to approximately 36 months

    ORR is defined as the percentage of participants who have a Complete Response (CR: Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions and includes no unequivocal progression in non-target lesions) per RECIST 1.1.

  3. Complete Response Rate（CRR）

    Time frame: Baseline up to approximately 36 months

    The rate of CR (Disappearance of all target and non-target lesions and also includes reduction of all nodal lesions to <10mm).

  4. Time to the first disease progression （TTP）

    Time frame: Up to approximately 24 months

    Ddefined as the interval between the date of the initial medication and the time of imaging progression.

  5. Duration of response (DOR)

    Time frame: Up to approximately 24 months

    Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression or death due to any cause, whichever occurs first.

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Induced and Concurrent Serplulimab Plus Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for Stage III-IVA Cervical Cancer: a Prospective, Multicenter, Randomized, Open Controlled Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2028
First posted
May 17, 2024
Registry last updated
May 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.